Surgical articles and methods

Abstract

Described are devices, implants, kits, and related methods for treating pelvic conditions such as urinary in incontinence, in a male or a female patient.

The invention claimed is: 
     
       1. An implant and adjusting tool for treating urinary incontinence, the implant comprising:
 a support portion piece comprising a proximal end, a distal end, an extension portion, a tissue support portion, and a self-fixating tip at the distal end, 
 an extension portion piece comprising a proximal end, a distal end, an extension portion, and a self-fixating tip at the distal end of the extension portion piece, and 
 a connector secured to the support portion piece, the connector comprising a first aperture that adjustably engages the extension portion piece, and a second aperture comprising a channel; and 
 the adjusting tool comprising a handle, an elongate shaft, and a distal end; 
 wherein the channel of the second aperture is adapted to engage the distal end of the adjusting tool while the first aperture is engaged with the extension portion piece, 
 wherein the connector comprises a proximal end and a distal end, the first aperture comprising a channel extending from the proximal end of the connector to the distal end of the connector, the channel of the second aperture extending from the proximal end of the connector at least partially to the distal end of the connector. 
 
     
     
       2. The implant and adjusting tool according to  claim 1  further comprising an insertion tool that is adapted to engage the self-fixating tip of the support portion piece, the self-fixating tip of the extension portion piece, or both. 
     
     
       3. The implant and adjusting tool according to  claim 1  wherein the proximal end of the extension portion piece extends through the first aperture to adjustably connect the extension portion piece to the support portion piece. 
     
     
       4. The implant and adjusting tool according to  claim 1  wherein the adjusting engagement is a one-way adjusting engagement. 
     
     
       5. The implant and adjusting tool according to  claim 1  wherein a length of the support portion piece is different from a length of the extension portion piece. 
     
     
       6. A method of treating incontinence in a male or female patient, the method comprising:
 providing the implant and adjusting tool of  claim 1 , 
 placing the self-fixating tip of the support portion piece at an obturator foramen on one side of the patient, 
 placing the self-fixating tip of the extension portion piece at an obturator foramen on one side of the patient, 
 placing the tissue support portion at a location to support tissue of a urethra, 
 adjustably engaging the proximal end of the support portion piece to the proximal end of the extension portion piece. 
 
     
     
       7. The method according to  claim 6  wherein the patient is a male patient and the method comprises exposing bulbospongiosus muscle, dissecting bulbospongiosus muscle to expose corpus spongiosum, and placing the tissue support portion to contact the corpus spongiosum. 
     
     
       8. A system useful to treat urinary incontinence, the system comprising a multi-piece implant comprising a support portion piece, two extension portions, and an adjusting tool,
 wherein the support portion piece comprises a tissue support portion sized and shaped for placement to support a urethra, 
 the extension portions each comprise a proximal end, a distal end, and a self-fixating tip, 
 the first extension portion is capable of being adjustably connected to the support portion piece at a first adjusting engagement, 
 the second extension portion is capable of being adjustably connected to the support portion piece at a second adjusting engagement, 
 the adjusting tool comprising:
 a surface adapted to engage one of the two extension portions and to place tension on the extension portion, 
 an end effector including an elongate shaft, 
 a pulling member slideably positioned relative to the elongate shaft and slidable along a length of the shaft, and 
 a force limiter comprising a spring connected to the surface and adapted to limit a force applied to the extension portion by the surface during surgical placement of the implant, the force limiter including a spring rod operatively coupled to the spring, the spring rod including a proximal extending member, the pulling member being operatively connected to a distal end of the spring, the proximal extending member being operatively connected to a proximal end of the spring, 
 wherein the spring has a longitudinal axis, the longitudinal axis being oriented substantially parallel to the length of the elongate shaft. 
 
 
     
     
       9. The system according  claim 8 
 wherein the end effector includes a distal end tip, and a thumb ring at a proximal end of the elongated member; 
 the pulling member comprising a main body adjacent to the elongated member of the end effector, and two finger rings positioned on opposite sides of the elongated member, 
 the spring being operatively connected to the pulling member for controlling slideable movement of the pulling member relative to the end effector. 
 
     
     
       10. The system according  claim 8  wherein the spring rod comprises a cross member, and an upwardly extending member at each of proximal and distal ends of the cross member, and wherein the upwardly extending member is operatively connected to a slot of the main body of the pulling member. 
     
     
       11. The system according  claim 10  wherein the force limiter comprises a pull force indicator that extends beyond at least one outer surface of the pulling member. 
     
     
       12. The system according to  claim 8  wherein at least one of the first adjusting engagement and the second adjusting engagement is selected from: a one-way adjusting engagement, a two-way adjusting engagement, and a locking two-way adjusting engagement. 
     
     
       13. A method of treating urinary incontinence, the method comprising
 providing the system of  claim 8 , 
 placing the self-fixating tip of the first extension portion on a first side of the patient, 
 placing the self-fixating tip of the second extension portion on a second side of the patient, 
 placing the tissue support portion at a location to support tissue of the urethra, and 
 using the adjusting tool to adjust the placement of the support portion piece relative to one of the two extension portions.